Overview of Enrollment Procedures

Training Materials for this session  All materials for this session can be found under the Enrollment tab of your training binder  We will be referencing Appendix 1 in your protocol.  An enlarged version of this can be found in the overview tab (cream color sheet)- this has been updated with LoA#1 and LoA#2.

Confirming eligibility and establishing baseline Admin and Behavioral procedures, per protocol Appendix 1: Enrollment and off-site IC conducted. Specimen storage is recommended but M1 is allowable. ** This is not a prerequisite for collecting the plasma archive at enrollment Behavioral, clinical and laboratory eligibility criteria. Behavioral eligibility criteria is not listed out explicitly below (captured on the Enrollment Behavioral Eligibility CRF (non- DataFax)) Baseline behavioral assessment (Baseline Behavior Assessment CRF; Enrollment ACASI) = eligibility = baseline

Confirming eligibility and establishing baseline Clinical procedures, per protocol Appendix 1/ LoA #1: Conduct if follow-up on an abnormality is needed or symptoms reported. Perform pelvic to provide f/up or address symptom (specimen collection not required if not indicated). Used as baseline if conducted Medical history is updated on the PRE as needed. Update the Scr Menstrual History CRF with any change in bleeding patterns. Reports at enrollment considered baseline Abbr. physical exam conducted. Conduct as needed in response to symptoms or exclusionary findings from screening

Confirming eligibility and establishing baseline Laboratory procedures, per protocol Appendix 1, LoA #1 and LoA #2: If blood tests meet exclusionary criteria at the Screening visit and warrant retesting they should be retested prior to Enrollment to allow TAT. Self-collected vaginal swab (= ‘vaginal fluid’ per protocol). Baseline plasma collection is critical in order to confirm eligibility into the trial for seroconverting participants

Confirming eligibility and establishing baseline Study product/supplies per protocol Appendix 1: Scr Enr

How is the enrollment visit different?  Confirm eligibility  Document baseline conditions  Randomize when the above is conducted and confirmed  Randomization is the act of enrollment for ASPIRE  Enrollment visits cannot be split

Participant HAS NOT been randomized:  Reschedule the participant for the enrollment visit (keeping in mind 28 day window)  ALL procedures repeated except administration of the informed consent(s)  No CRFs from an incomplete enrollment visit should be faxed to SCHARP (but they should be maintained in the participant file)

Participant HAS been randomized:  The visit is considered her enrollment visit even if all procedures were not conducted  If the participant did not receive the study product she should be scheduled to come in as soon as possible- to get the study product, first product use/ digit exam/ debrief, and first ring use education session conducted

What if plasma archive is missed?  This is necessary to confirm eligibility as needed later in the trial and should always be collected prior to randomization (before contact with study product).  She should be scheduled to come in as soon as possible for the collection of this

Order of visit procedures at enrollment is important What are the key procedures of the enrollment visit that must be conducted in the correct order? 1. Enrollment IC 2. Eligibility confirmation 3. Behavior assessments (CRF, ACASI), blood collection for plasma archive, self-collected swab (per LoA#2) 4. Randomization 5. Study product provision/related procedures

ENROLLMENT VISIT CRF DOCUMENTATION

 Captures dates of screening and enrollment IC  Item 3: Mark ‘pending’ box and update later if post- study storage consent not presented at EV; change response as needed if ppt changes her mind  HIV/pregnancy items used to document in the database the ppt’s eligibility  Randomization info is transcribed from Randomization/ Prescription Tracking Record for Clinic  Items 9-12: if not done on same day as randomization (item 7), mark ‘no’ (items are considered missed)  Note: Of 9-12, only plasma archive specimen needs to be made up if not done on day of randomization Enrollment (ENR-1)

 Collects info on whether the participant was enrolled in  VOICE  other microbicide trials  PrEP trials  any other research studies  Collects how the participant heard about ASPIRE  VOICE participation must be confirmed with a PTID; other items are per ppt self report  Will provide information on how ‘active’ ASPIRE ppts are in research trials overall and across sites Prior Trial Participation (PTP-1)

Enrollment Behavioral Eligibility  Non-DataFax  One page, used to confirm behavioral eligibility criteria at EV  Interviewer administered, translated, read aloud word-for-word  Complete all items  Provide clarity as needed  Complete all items, regardless of ppt’s responses

 Complete based on ppt self-report  Mark all methods the participant is currently using; do not include methods she is planning to use’  Items 1e-1i: Record date the ppt started using that particular method  record on Con Meds Log also; dates of use may differ  Item 1g1 – mark specific type of injectable used Baseline Family Planning (BFP-1)

 Items 2, 3: Record dates (or amenorrheic for past 6 months) as of the EV. Purpose is status of menses at time of visit.  If item 3 is ongoing, do not go back and update at Month 1  Items 2 and/or 3 may duplicate information captured at the SV on the SMH form – that is fine  Item 4: based on ppt self-report (medical records not needed) Baseline Family Planning (BFP-1) – con’t

 Items 1-7 are required to be assessed  Vitals, general appearance, abdomen/gastrointestinal  All items require a response  Mark ‘not done’ for Items 8-17 if not assessed  Update PRE as needed  Add new conditions as needed  Complete “Ongoing at Enrollment” for any previously-recorded conditions as needed Enrollment Abbreviated Physical Exam (EPX-1)

 Allows SCHARP to report on  # screened  # enrolled  # screen fails  reasons for screen failures  Complete and fax for all participants who start an EV, even if they do not enroll (only form faxed if not enrolled)  If a participant screen fails, then screens again  Always update and re-fax original ECI completed for the participant - do not complete a 2 nd (new) ECI CRF Eligibility Criteria (ECI-1)

Baseline Behavior Assessment (BBA)  Interviewer-administered, translated, read aloud word-for-word  Complete all items; provide clarity as needed  Page 1 collects info on primary sex partner: his HIV status, use of ARVs, circumcision status, study/ring disclosure status, clinic attendance Item 7 (partner’s ARV use) is asked regardless of whether partner HIV status is known (per item 6)

Baseline Behavioral Assessment – con’t BBA PAGE 2  Other sex partners, frequency of vaginal sex (past 3 months, 7 days), anal sex, condom use BBA PAGE 3  Ppt’s worries about the ring  Item 17: If ppt is ‘very worried’ about using a ring for at least one year, site may want to re-consider whether to enroll her or not  Item 18: each specific ring use worry requires a yes/no response. This item will be asked again at Month 3 and PUEV/early termination

Baseline Vaginal Practices (BVP-1)  Interviewer-administered, one page  Captures use of products that may alter vaginal/intravaginal environment  Collects info on vaginal items used during menses and in general  These same questions will be asked every 6 months and at PUEV/early termination

Enrollment Visit LDMS Tracking Sheet Optional form Collection of specimens captured on ENR CRF (items 10, 11) Visit Code has been pre-printed = 98.0

 During visit:  Review the 3 interviewer-administered CRFs to ensure completeness and skip patterns followed  Make sure eligibility is confirmed per SOP prior to randomization  Review visit checklist to make sure all required procedures completed, including plasma archive collection  If Randomized/Enrolled  Fax all appropriate SV and EV forms to SCHARP  Fax appropriate lab results/pelvic exam CRFs I n cases where repeat results are available Enrollment Visit QA/QC

Resolving QCs on Interviewer Administered CRFs If item is marked and it should not have been completed: Line through the marked box, initial date and refax [In this example, can use brackets for 8a through 8c]

Resolving QCs on Interviewer Administered CRFs If item is not marked and it should have been completed: Line through the item boxes, initial date and refax Use white space next to item to explain ‘item was missed in error’

Screening/Enrollment/ Eligibility Scenarios

 Will get into groups for small group discussion  Handout of all scenarios - please talk through all of the scenarios and questions included for each scenario  Review answers as you go with group leader/Training Team Rep  Will discuss questions as a group at end Scenario Instructions

References  Protocol Section 7.3 (Enrollment)  Protocol Appendix 1  SSP:  Section 4.4 (Enrollment Procedures)  Section 10.1 (Baseline Medical Conditions)  Section 14 (Data Collection)